Fully automated specific protein analyzer
- Device class
- Class II
- Model specifications
- BioYu
- Approval department
- Chongqing Municipal Drug Administration重庆市药品监督管理局
- Registration number
- 渝械注准20242220521
- Approval date
- December 31, 2024
- Expiry date
- December 30, 2029
- Name
- Chongqing Biostec Biological Technology Co., Ltd.重庆博士泰生物技术有限公司
- Province/Region
- Chongqing重庆
- Address
- 1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing重庆市南岸区长生桥镇茶花路17号2幢1、2楼
- Production address
- 重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
The product is used in conjunction with matching reagents for the quantitative detection of specific proteins in human samples through scattering nephelometric dual optical path technology.
该产品通过散射比浊法双光路技术，与配套的试剂共同使用，用于对人体样本中特定蛋白的定量检测。
本设备由光学系统、机械运动系统、液路系统、电子控制系统和软件组成;本产品组成中的软件为外控型软件组件.
本设备由光学系统、机械运动系统、液路系统、电子控制系统和软件组成；本产品组成中的软件为外控型软件组件。
- Remark
- 首次注册。
Access comprehensive regulatory information for Fully automated specific protein analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20242220521 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on December 31, 2024.
This page provides complete registration details including registrant information, province location (Chongqing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.